Lumbosacral Spondylosis, Radiculopathy, Spinal Stenosis
Conditions
Brief summary
The purpose of this study is to determine the effects of different rates of Caudal Epidural Steroid Injection (CESI) on clinical outcomes of the patients.
Interventions
DRUGTriamcinolone Acetonide and normal saline solution
80 mg/2 ml Triamcinolone Acetonide and 18 ml normal saline solution
Sponsors
Navamindradhiraj University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* lumbosacral spinal stenosis with radiculopathy * no improvement after conservative treatment for 6 weeks
Exclusion criteria
* previous CESI or spinal surgery * skin infection at injection site * uncontrolled diabetes mellitus * abnormal coagulogram * vertebral fracture * previous history of allergy to steroid or anesthetic agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline Visual Analogue Scale at 2, 6, 12 weeks | 2, 6, 12 weeks |
| Change from baseline Roland 5-point pain scale at 2, 6, 12 weeks | 2, 6, 12 weeks |
| Change from baseline Standing tolerance test at 2, 6, 12 weeks | 2, 6, 12 weeks |
| Change from baseline Walking tolerance test at 2, 6, 12 weeks | 2, 6, 12 weeks |
| Change from baseline Patient satisfaction scale at 2, 6, 12 weeks | 2, 6, 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Complication of Caudal Epidural Steroid Injection | 2, 6, 12 weeks |
Countries
Thailand
Outcome results
None listed